pharmaceutical congress asia 2015

IBCLIFE SCIENCES

www.pharmaconasia.com

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4 Conferences in 1 Location

3 - 6 August 2015 | Grand Copthorne Waterfront Hotel, Singapore

The leading event that brings together Asia’s leading pharmaceutical companiesand its suppliers in one place!

Distinguished Global & Regional Speakers Include:

Carl Firth

Chief Executive Officer,Aslan Pharmaceutical, Singapore

Churn-Shiouh GauExecutive Director, Center for Drug

Evaluation,Taiwan Food and Drug

Administration (FDA), Taiwan

Jimmy Zhang

Vice President, Transactions,Johnson & Johnson Innovation,

China

Stewart GearyChief Medical Officer, Senior Vice President,General Manager, Corporate Medical Affairs

Headquarters, Global Safety Board Chair,Eisai, Japan

Eva Kopecna

Head, Regulatory Affairs-Global OTC,Teva, UK

Tadashi Fujisawa

Chief Executive Officer,Mebiopharm, Japan

James Garner

Head, Unit Development Operations,Asia R&D,

Sanofi, Singapore

Robert Braithwaite

Founder & CEO,Luqa Pharmaceuticals, China

Maggie LimDirector, Asia Pacific Clinical

Development Quality Assurance,R&D Global Quality & Compliance,

GlaxoSmithKline, Singapore

Jin-San Yoo

President & CEO,PharmAbcine, South Korea

Talita Hilse

Senior Director,Global Clinical Operations,

Takeda Pharmaceuticals, Switzerland

Anirban Roy Chowdhury

Senior Director,Global Clinical Operations,

Merck & Co., India

Ajay Tiku

Vice President Medical, Asia Pacific,North & South Asia,

GlaxoSmithKline, Singapore

Andrew Eggleston

JAPAC Market Access & Policy Director,Abbvie, Singapore

R. Byron Sigel

Director, Patient Innovation Policy,Baxalta, Japan

Dominique Milea

Director Health Economics &Epidemiology Asia,

Lundbeck, Singapore

What’s New for 2015:Latest country-focused updates on regulation and market trendsReal-life case studies from 18+ countries

80+ renowned speakers from leading pharmaceutical companies1 shared exhibition room to showcase latest technology and services4 days of expert knowledge sharing180+ attendees to network with

Optimizeyour Time &

Money with aGOLD PASS


3 - 6 August 2015

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Designed for professionals in clinical trial value chain, Clinical Trials Asia zeroes in on the latest new trial markets in Asiaand the newest trends in operational excellence for Asia. This event aims to accelerate cost-efficient clinical developmentthat meets global trial standards for big pharma, local pharma and biotech in Asia. It discusses how to achieve the qualityrequirements for meeting global clinical standards, accelerating trial timelines in Asia Pacific, examining the individualclinical capabilities in Asia Pacific and most cost-effective ways to conduct trial operations in Asia. Find out how to smoothlyintegrate Asia Pacific into global clinical trials with a focus on enhancing trial quality, improved research outcomes andaccelerated timelines for drug approvals at the ONLY senior platform for Clinical Research Excellence in Singapore for 2015.

WHO SHOULD ATTEND?VPs, Directors, Heads, Managers, Team Leaders of:

The leading platform for regulatory expertsto be updated with latest country updatesand strategies to navigate the complex andever changing regulations in the region. Gooddepth & breadth of discussions include bothcountry-centered and product- focusedregulatory strategies for ease of productaccess into regional and international markets.Accelerate your approvals to fast-track yourdrugs to the market.

WHO SHOULD ATTEND?VPs, Directors, Heads, Managers of:• Global/ Regional Regulatory affairs• Regulatory Submissions• Regulatory Compliance• Drug Development & Regulatory Affairs• Medical & Regulatory Affairs• Regulatory & Government Affairs• Regulatory Policy• Regulatory Intelligence

MARKETACCESS2015RMAPHAPHAPHA RMA

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Designed for regional and countrymanagers and senior executives frommarketing, commercial development,Government affairs and businessdevelopment, the conference pinpoints keysuccess factors in strategizing market entryin Asia’s complex diverse, competitive andgrowing pharmaceutical market. This eventis Asia’s one and only platform to provideupdated and in-depth evaluation onprofitable and successful market entries.

WHO SHOULD ATTEND?• CEO• President/Managing

Director/Vice President of Asia• Country Manager• Regional Marketing Director• Head of Corporate Planning• Head of Government Affairs• Head of Marketing & Sales

• Head of Market Access &Pricing

• Head of Health Economics• Head of Business Development• Head of Commercial• Head of Product Development• Head of Procurement &

Sourcing• Head of Compliance

Join us at IBC Asia’s 4th Medical Affairs Forum2015 – the region’s longest running strategyforum where leading medical affairs professionalsshare best practices, discuss common issues andlearn from industry experts to enhance scientificreputation, sustain collaboration, build theirbrand names and achieve success. Gain insightsinto how to balance both scientific andcommercial roles, engage in effective cross-functional team collaborations, and formmutually beneficial partnerships with KOLs toget ahead and drive success.

WHO SHOULD ATTEND?• Chief Medical Officers• Vice President/Director, Medical Affairs• Head, Medical and Regulatory Affairs• Medical and Scientific Affairs• Medical and Clinical Affairs• Medical Directors• Medical Affairs Managers• Medical Advisors• Medical Affairs Associates• Medical Science Liaisons• Medical Writers

Grand Copthorne WaterfrontHotel, Singapore

REGISTER TODAY! +65 6508 2401 [email protected] www.pharmaconasia.com

• Clinical Operations• Clinical Development• R&D• Drug Development• R&D business operations• Clinical Trial Co-ordination• Clinical Quality Assurance• Clinical Compliance

• Inspection Readiness• Clinical Supply Chain

Management• R&D Outsourcing• Procurement• Strategic Partnerships and

Alliances• Business Development

• Partnership Strategies• Medical Affairs• Project Management• Project Leadership• Trial Site Management• Onsite-monitoring• Clinical Resourcing• Global/regional APAC Monitoring

• Biometrics and Medical Writing• Data Management• Clinical Research Associate (CRA)• Strategic Outsourcing• Clinical Trial Monitoring• Project / Trial Start-up

• Regulatory strategy• Product Development• Clinical Development• Regulatory publishing• Pharmacovigilance• QA/QC


4 August 2015CONFERENCE DAY ONE

Tuesday


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8.00 Registration Opens & Morning Coffee

8.45 Welcome Address from IBC Asia & Speed Networking

8.50 Chairperson’s Opening Remarks

ASIA PHARMA MARKET OUTLOOK

9.00 Keynote Big Pharma Panel: What are the Key Commercial Considerations for Successful Drug Research, Investment & Development in Asia?

Panelists:Yariv Hefez, Vice President, Strategic Development, Business Development, Portfolio Management and Partnering, Biosimilars, Merck Serono, SwitzerlandStewart Geary, Chief Medical Officer, Senior Vice President, General Manager, Corporate Medical Affairs Headquarters, Global Safety Board Chair, Eisai, JapanJames Garner, Head, Unit Development Operations, Asia R&D, Sanofi, SingaporeJimmy Zhang, Vice President, Transactions, Johnson & Johnson Innovation, China

9.30 Keynote Regional CEO Panel: What is the Impact of Globalization on Drug Development for Biotech and Local Pharma?

Panelists:Tadashi Fujisawa, Chief Executive Officer, Mebiopharm, JapanRobert Braithwaite, Founder & CEO, Luqa Pharmaceuticals, ChinaJin-San Yoo, President & CEO, PharmAbcine, South KoreaCarl Firth, Chief Executive Officer, Aslan Pharmaceutical, Singapore

10.00 Special Government Panel: Regulatory Convergence, Drug Development Pathways and Access in Asia

Panelists:Churn-Shiouh Gau, Executive Director, Center for Drug Evaluation, Taiwan Food and Drug Administration (FDA), TaiwanMaria Victoria Calub, Food-Drug Regulation Officer IV, Food and Drug Administration (FDA), PhilippinesAndrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety (AGES) PharmMed & Member, Committee for Medicinal Productsfor Human Use (CHMP), European Medicines Agency (EMA), AustriaNguyen Ngo Quang, Deputy Director, Administration of Science, Technology and Training (ASTT), Vietnam Ministry of Health, Vietnam

10.30 Morning Networking & Refreshment Break

Choose Your Own Sessions From 3 Different Tracks

11.15 Chairperson’s Opening Remarks Chairperson’s Opening Remarks

Michel Mikhail, Expert in International GlobalRegulatory Affairs, Germany

Chairman’s Opening Remarks

Rafael Mendoza, Regional Therapeutic Lead – GlobalInnovative Pharma, Pfizer, USA

11.20 Clinical Trial Market Opportunitiesin Asia Pacific

Country-Focused Regulatory Updates& Clarification of Guidelines

Country Updates, Investments &Expansion

Keynote Panel Discussion:

Where are Big Pharma and Biotech Looking for

Clinical Trials in Asia Pacific?

Panelists:Stewart Geary, Chief Medical Officer, Senior VicePresident, General Manager, Corporate Medical AffairsHeadquarters, Global Safety Board Chair, Eisai, JapanJason Yang, Senior Vice President and Head of ClinicalDevelopment, BeiGene, ChinaAnirban Roy Chowdhury, Senior Director, GlobalClinical Operations, Merck & Co., IndiaJames Garner, Head, Unit Development Operations,Asia R&D, Sanofi, Singapore

Latest Country Updates & Regulatory

Environment Overviews

Taiwan

Churn-Shiouh Gau, Executive Director/Center for DrugEvaluation, Taiwan FDA

Philippines

Maria Victoria P. Calub, Food-Drug Regulation OfficerIV, FDA Philippines

Vietnam

Thao Nguyen, Regulatory and Government AffairsDirector, Roche Vietnam

Keynote Panel:

Challenges in Asia’s Changing Healthcare

Economics and Improving the Commercial

Success of New and Established Products in Asia

Moderator:Dr Allan Lai, Vice President, International Society

of Pharmacoeconomics and Outcome Research,SingaporePanelists:R. Byron Sigel, Director, Patient Innovation Policy,Baxalta, JapanMarcelina ‘Ace’ Itchon, President and CEO, Aspen

Philippines, Inc, PhilippinesJittrakul Leartsakulpanitch, Head, Market Access,Asia Pacific, Janssen, SingaporeNathan Kothandaraman, Lead, Government Affairs,Johnson & Johnson, Malaysia

12.00 Case Study:

Regulatory Update Relating to Clinical Trial

Conduct in Vietnam

Nguyen Ngo Quang, Deputy Director,Administration of Science, Technology and

Training (ASTT), Vietnam Ministry of Health,VietnamTran Thi Minh Nguyet, Co-founder, General Manger,Smart Research, Vietnam

Investment & Market Updates in Asia

Vijay P. Karwal, Managing Director, Co-Head ofMergers & Acquisitions, Head of Industrials, Consumer& Healthcare, CIMB Investment Bank, Hong Kong


4 August 2015CONFERENCE DAY ONE

Tuesday


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2.00Early Phase Clinical Developmentfor Niche Biologics in Asia Pacific

Country-Focused RegulatoryUpdates & Clarification of

Guidelines (continued)

4.30

12.50 Networking Lunch & VIP Tables

VIP Table 1: Nguyen Ngo Quang, Deputy Director, Administration of Science, Technology and Training (ASTT),Vietnam Ministry of Health, VietnamVIP Table 2: Stewart Geary, Chief Medical Officer, Senior Vice President, General Manager,Corporate Medical Affairs Headquarters, Global Safety Board Chair, Eisai, JapanVIP Table 3: Feng Guo, Head, R&D, Merck Serono, ChinaVIP Table 4: Churn-Shiouh Gau, Executive Director, Center for Drug Evaluation, Taiwan Food and Drug Administration (FDA), TaiwanVIP Table 5: Maria Victoria Calub, Food-Drug Regulation Officer IV, Food and Drug Administration (FDA), PhilippinesVIP Table 6: Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety (AGES) PharmMed & Member, Committee for MedicinalProducts for Human Use (CHMP), European Medicines Agency (EMA), AustriaVIP Table 7: Andrew Eggleston, JAPAC Market Access & Policy Director, Abbvie, SingaporeVIP Table 8: Irene Chen, Regional Market Access and Pricing Lead, Asia Oceania, Astellas Pharma, SingaporeVIP Table 9: Bruno Rossi, Senior Advisor, Market Access and Health Policy, Bayer HealthCare, Japan

Bring yourquestions and get to

know industry expertswhilst having lunch

China Case Study:Creating a Successful Specialty PharmaCompany in China – Opportunities & ChallengesRobert Braithwaite, Founder & CEO, LuqaPharmaceuticals, China

The Ecosystem for Early Phase and Translational

Clinical Research in Singapore: Where are the

Gaps and Opportunities?

Danny Soon, Former Managing Director, Lilly-NUS,Medical Director, Drug Discovery and

Development (D3), A*Star, Singapore

Indonesia

Ikhsan Rambia, Head of International RegulatoryAffairs, Sanbe Farma, Indonesia

Thailand

Noppadon Adjimatera, SEA Regional Regulatory andMedical Affairs Director, Reckitt Benckiser, Thailand

Japan

Koichi Miyazaki, Senior Director, Regulatory AffairsGroup, Asia Development Department, Daiichi

Sankyo, Japan

2.40

Philippines Case Study:Realizing the Full Potential of Philippines’Unique MarketMarcelina 'Ace' Itchon, President and CEO, AspenPhilippines, Inc, Philippines

Case Study:

Early-Phase Clinical Development Pathway for

mAb Biologics in Korea

Jin-San Yoo, Chief Executive Officer, President,PharmAbcine, Korea

Indonesia Case Study:Indonesia’s Universal Healthcare Coverage: Howcan Foreign Pharma Companies Leverage &Remain Profitable in the Market?Dr. Luthfi Mardiansyah, Chairman, InternationalPharmaceutical Manufacturer Group (IPMG),President Director, Novartis, Indonesia

3.20 Afternoon Networking & Refreshment Break

3.50 Designing an Effective Corrective Action

Preventive Action (CAPA) Management System

for Conducting Clinical Trials in Asia

Maggie Lim, Director, Asia Pacific ClinicalDevelopment Quality Assurance, R&D Global Quality& Compliance, GlaxoSmithKline, Singapore

China

Victoria Elegant, Vice President, Medical & RegulatoryAffairs, Baxter, China

India

Premnath Shenoy, Regulatory Affairs Director,AstraZeneca, India

Thailand Case Study:

Maintaining Profit Margins under Universal

Healthcare in Thailand

Paul Uthaichalanond, Director, Vaccine Sub-ClusterLead - Thailand, Indonesia and Vietnam, Pfizer,

Thailand

Case Study:

Quality Assurance Measures and Compliance in

Asia Trials: Ensuring Readiness for FDA

Inspections

Seema Gaonkar, Global Clinical Quality AssuranceManager, Lundbeck, Singapore

Accelerating Patient Access to Medicines via

Adaptive Licensing and Approval Pathways

Andrea Laslop, Head of Scientific Office, AGES,

PharmMed, Austria and Austrian member, CHMP,

EMA (European Medicines Agency)

5.10 Roundtable Discussions

Role of Academic Research Institutes in GlobalClinical Trial OperationsIsabelle Lee, Head, Research Operations & ProjectManagement, Singapore Clinical ResearchInstitute, Singapore

Comparisons of CMC Variations in the Region &Managing ComplicationsTong-Lay Crystal Lau, Senior Technical RegulatorySpecialist (Global), GlaxoSmithKline, Singapore

Current Compliance Issues for Pharma

Companies

Redentor Romero, Regional Compliance Officer,Teva Pharmaceuticals, Singapore

Monitoring Trip Reports in Asia: BalanceBetween Optimization Time, Dynamic TripReports and Recording of Critical InformationJuliana Wang, Onsite Monitoring and ResourcingManager, South East Asia, Boehringer IngelheimPharmaceuticals, Singapore

Strategies for Handling Products in MultipleCountriesJack Wong, Director, Regulatory Affairs Asia Pacific,Terumo BCT, Singapore, Founder of Asia RegulatoryProfessional Association (ARPA)

Opportunities under Universal HealthcareCoverage in IndonesiaBernardus Sidharta, former COO/DirectorCommercial Operation & Development, Merck,President & Managing Director, PT Rama EmeraldMulti Sukses, Indonesia

Trial Site Selection in Asia Pacific: The RightCountry, the Right Site and the Right PartnerPrabhuram Krishnan, Medical Director, Eli Lilly andCompany, Philippines

Regulatory Intelligence when DevelopingRegulatory Strategies for a Global MarketMichel Mikhail, Expert in International GlobalRegulatory Affairs, Germany

Market Entry for Established Pharma ProductsRafael Mendoza, Regional Therapeutic Lead – GlobalInnovative Pharma, Pfizer, USA

Chairperson’s Summary & End of Conference Day One6.00

Panel Discussion:

Biosimilars – Where is it Heading & How to Access

the Asian Market Profitably?

Panelists:Yariv Hefez, Vice President, Strategic Development,Business Development, Portfolio Management andPartnering, Biosimilars, Merck Serono, SwitzerlandSreeraj Roy, Business Director, Pfizer, Indonesia


5 August 2015CONFERENCE DAY TWO

Wednesday


RMA

11.00

9.00

9.50


12.20

11.40

Chairperson’s Opening Remarks Chairperson’s Opening Remarks


Chairperson’s Opening Remarks

Salman Bokhari, Managing Director, Sidrapex,Singapore

9.10Partnerships and Outsourcing

Strategies

Identifying Regulatory Pathways &Crafting Regulatory Strategies for

Key Products

Real World Evidence and HealthEconomic Outcome Research

Examining Innovative R&D Collaboration

Strategies for Asia

Yariv Hefez, Vice President, Strategic Development,Business Development, Portfolio Management andPartnering, Biosimlars, Merck Serono, Switzerland

Panel Discussion:Comparison of Regulatory Trends and Impactson Business Strategy: APAC vs InternationalRegulatory Models FDA/EMA

Moderator:Ng Cheng Tiang,Asia Regulatory Affairs RegionalDirector, Teva, SingaporePanelists:Michel Mikhail, Expert in International GlobalRegulatory Affairs, GermanyChau Giang Le, Vice President, Regulatory Affairs andScientific Engagement APAC, Johnson and Johnson,Singapore

Creating and Using RWE (Real World Evidence)

in Support of Market Access

R. Byron Sigel, Director, Patient Innovation Policy,Baxalta, Japan

Panel Discussion:Key Considerations in CRO Selection for Trialsin Asia

Panelists:Talita Hilse, Senior Director, Global ClinicalOperations, Takeda Pharmaceuticals, SwitzerlandSeema Gaonkar, Global Clinical Quality AssuranceManager, Lundbeck, SingaporeSachin Pasumamula, Regional Global MedicalOperations Compliance Head, Region International,Asia Pacific and Middle East, Formerly NovartisVaccines, GlaxoSmithKline, SingaporeValerie Tan, Asia Pacific & South Africa Head, GlobalMedical Operations, Novartis Asia Pacific,Singapore

Regulatory Strategies for OTC Drugs

Eva Kopecna, Head, Regulatory Affairs-Global OTC,Teva, UK

Creating a Sustainable Health Economics &

Outcomes Research Strategy

Bruno Rossi, Senior Advisor, Market Access andHealth Policy, Bayer HealthCare, Japan

Efficient and Cost-Effective TrialOperation in Asia

Pricing & Reimbursement

Strategies for: Biosimilars & Vaccines – Key APAC

Markets


Critical Considerations in Quality for the Clinical

Supply Chain Operations in Asia Pacific

Senior Representative, ALMAC

Case Study:

Optimal Market Access and Pricing &

Reimbursement (P&R) Strategies

Jittrakul Leartsakulpanitch, Head, Market Access,Asia Pacific, Janssen, Singapore

Panel Discussion:Understanding the Concepts of Risk-BasedMonitoring for Clinical Trials

Moderator:Seema Gaonkar, Global Clinical Quality AssuranceManager, Lundbeck, SingaporePanelists:Pei Yin Tan, Associate Director, Head of Asia ClinicalOperations, Eisai Clinical Research, SingaporeValerie Tan, Asia Pacific & South Africa Head, GlobalMedical Operations, Novartis Asia Pacific,Singapore

Generics Regulatory Pathways

Krishna Prasad, Associate Director Regulatory Affairs,Actavis, Singapore

Out-licensing & Partnership

Is Out-licensing an Efficient Way to Accelerate

Market Penetration in New Markets?

Lalit Baregama, General Manager – GlobalDevelopment, Cadila Pharmaceuticals, India

Accelerating Clinical Trial Timelines Cost-

Effectively in Asia PacificRegulatory Pathways for Medical Device and

Combination Products in Asia

Jack Wong, Director, Regulatory Affairs Asia Pacific,Terumo BCT, Singapore, Founder, Asia Regulatory

Professional Association (ARPA)High Priced Therapeutics

Building up a Credible Health Economic

Database for High Price Therapeutics Drugs

Dominique Milea, Director Health Economics &Epidemiology Asia, Lundbeck, Singapore

Staying Ahead of Your Competitors in

Evidence-Based World – Models for Success

Seng Chuen Tan, Regional Director, HEOR andReal-World Evidence, IMS Health, Singapore



RMA

4.40

1.00 Networking Lunch & VIP Tables

VIP Table 1: Elaine Wang, Director, Clinical Development and Medical Affairs, Respiratory,Boehringer Ingelheim, USAVIP Table 2: Sivabalan Sivanesan, Director, Medical and Regulatory Affairs, Roche Pharmaceuticals, MalaysiaVIP Table 3: Keisuke Shiroyama, R&D Procurement Manager, Janssen, Johnson & Johnson, JapanVIP Table 4: Vo Thi Nhi Ha, Vice Head, Division of Clinical Trial Management,Administration of Science, Technology and Training (ASTT), Vietnam Ministry of Health, VietnamVIP Table 5: Manish Garg, Medical Director, MSD Pharmaceuticals, SingaporeVIP Table 6: Jeonghoon Han, Regional Medical Director, APAC, Teva Pharmaceuticals, SingaporeVIP Table 7: R. Byron Sigel, Director, Patient Innovation Policy, Baxalta, JapanVIP Table 8: Jackie Tieng, Head of Marketing, Takeda Pharmaceuticals, TaiwanVIP Table 9: Jittrakul Leartsakulpanitch, Head, Market Access, Asia Pacific, Janssen, Thailand

Bring yourquestions and get to

know industry expertswhilst having lunch


2.40

Chairperson’s Summary & End of Conference! See You Next Year!6.00

5 August 2015CONFERENCE DAY TWO

Wednesday

2.00Modernizing and Transforming

Clinical Practices in AsiaRegulatory Considerations forClinical Development and NDA

Case Study:

Early Access Program and Orphan Indication for

Accelerated Approvals

Elaine Wang, Director, Clinical Development andMedical Affairs – Respiratory, Boehringer

Ingelheim, USA

Transforming the Landscape of Trial Technology

in Asia: Application of ePRO Systems for Clinical

Data Management

Senior Representative, ERT

Panel Discussion:

Multi Regional Clinical Trials (MRCTs) for

Accelerated Drug Development

Panelists:Shun Jin, Regulatory Policy & Intelligence Director,JAPAC, AbbVie SingaporeYuko Kikuchi, Senior Director Asia Regulatory Affairs,Eisai, JapanKoichi Miyazaki, Senior Director, Regulatory AffairsGroup, Asia Development Department, Daiichi

Sankyo, Japan

Bridging Gaps in Meeting Trial Timelines:

Effective Communication Between Biometrics

and Clinical Trial Operations

Lot Yin Teng, Director, Biometrics and MedicalWriting, Lundbeck, Singapore

Overcoming Challenges in Filing for New Drug

Application (NDA) across Asia

Bindoo Chahal, Regulatory Affairs Director, SEA,Lundbeck, Malaysia

Case Study:

Successful Market Access for Oncology Products

in Asia

Jackie Tieng, Head of Marketing, Takeda

Pharmaceuticals, Taiwan

4.00Achieving Operational Excellence in

Delivering Dossier Submissions

Creative Strategies for Pharma to Address the

Challenges of Patient Recruitment & Retention

Anirban Roy Chowdhury, Senior Director, GlobalClinical Operations, Merck & Co., India

Case Study:

Formulating an Effective Market Access Strategy

in Diabetes

Dr Viraj Rajadhyaksha, Medical Director, TherapyArea Lead, Diabetes Portfolio Asia Area, AstraZeneca,Singapore

Preparing Global Dossiers Effectively – Cross

Regional Submission Advice

Ikhsan Rambia, Head of International RegulatoryAffairs, Sanbe Farma, Indonesia

What is Next for Clinical Trialsin Asia?

Post Market SurveillanceEssentials & Compliance

IP and Legal Issues

Panel Discussion:

Which is the Next Big Trial Destination in Asia?

Panelist:Danny Soon, Former Managing Director, Lilly-NUS,Medical Director, Drug Discovery and

Development (D3), A*Star, Singapore

CMC Variation Essentials in Lifecycle Management

Tong-Lay Crystal Lau, Senior Technical RegulatorySpecialist (Global), GlaxoSmithKline, Singapore

Case Study:

IP Litigation and Policy – Highlights and Recent

Development in India and Asia

Sandeep Rathod, Vice President/Head IP Litigationand Policy (India and Emerging Markets), Mylan

Laboratories, India

Variations in Post Market Surveillance Across the

RegionPatent Strategies under Competitive Landscape

Dr Amin Trehan, Director (Head) – IntellectualProperty, Novel Laboratories, USA

5.20

SPONSORSHIP SOLUTIONS CAN BE TAILORED TO YOUR NEEDS!To position your company as a market leader at this event, and to explore the range of thought leadership, speaking, branding andmarketing opportunities available, please contact Yvonne Leong • Tel: +65 6508 2489 • Email: [email protected]


FORUMSConference Forum: 3 August 2015 | Monday

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9.00 Chairperson’s Opening RemarksKiran Marthak, Global Head, Director, Clinical Development,Member of Board of Directors, Lambda Therapeutic Research,India

9.10 CRO Market Outlook: Past, Present and Future

Panelists:Anand Tharmaratnam, Senior Vice President, Head of Asia Markets,Member of Quintiles Executive Committee, QuintilesTransnational, SingaporeAlistair Macdonald, Chief Operating Officer, Global President,INC Research, UKAlbert Liou, Vice Chairman for Asia Pacific, PAREXELInternational, Taiwan

10.10 How Does Asia Fit into the Global CRO Strategy?Alistair Macdonald, Chief Operating Officer, Global President,INC Research, UK


11.40 Evolving CRO Business Models in Asia: 2015 and BeyondAlek Safarian, Chief Executive Officer, Novotech, Australia

12.40 Managing an Efficient Functional Service Provision Modelin AsiaRabinder Buttar, President, Chief Executive Officer and Founder,ClinTec International Group, UK

Conference Forum: 6 August 2015 | Thursday

9.00 Chairperson’s Opening RemarksTimothy Low, Vice President, Medical Affairs APAC, Medtronic,Singapore

9.10 Overcoming Challenges in a Cross Functional Team &Meeting Expectations of All Stakeholders

Panelists:Ajay Tiku, Vice President Medical, Asia Pacific, North & South Asia,GlaxoSmithKline, SingaporeStewart Geary, Chief Medical Officer, Senior Vice President, Eisai,JapanVictoria Elegant, Vice President, Medical & Regulatory Affairs,Baxter, China

9.50 Develop a Medical Strategy that Aligns with Business GoalsJeonghoon Han, Regional Medical Director, APAC, TevaPharmaceuticals, Singapore


11.00 Creating Synergies between Marketing & Medical AffairsSivabalan Sivanesan, Medical and Regulatory Affairs Director,Roche, Malaysia

11.40 Strategic KOL Engagement and Management

Dr Timothy Low, Vice President, Medical Affairs APAC, Medtronic,SingaporeManish Garg, Medical Director, MSD Pharmaceuticals,SingaporePrabhuram Krishnan, Medical Director, Eli Lilly and Company,Philippines

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Networking Luncheon

2.40 Leadership Through Operational Excellence: IntegratingAsian Operations into Global Clinical Trial Operations forCROsYeo Jing Ping, Vice President, Project Leadership APAC, ParexelInternational, Singapore

3.40 Considerations in Clinical Quality CROs Conducting ClinicalTrials in Asia PacificMonelle Payet, Director, Clinical Quality Assurance, ICON ClinicalResearch, Singapore


5.10 How Are the Drug-Development Collaboration Models forPharma and CRO Changing in Asia?

6.10 Chairperson’s Closing Remarks & End of Forum

1.30 Clinical Development and Medical Affairs: RealizingSynergies for Successful DrugsVictoria Elegant, Vice President, Medical & Regulatory Affairs,Baxter, China

2.10 Effective Management of Observational Studies andInvestigator-Initiated Studies (IIS)Stewart Geary, Chief Medical Officer, Senior Vice President, Eisai,Japan

2.50 High Performing Medical Science Liaisons Teams and KeySuccess FactorsAjay Tiku, Vice President Medical, Asia Pacific, North & South Asia,GlaxoSmithKline, Singapore


4.00 Addressing Success Factors and Hitting the KPI in MedicalAffairsDr Abhishek Bhagat, Head, Medical Science & Regional MedicalDirector, Consumer Health Asia, Merck Group, Singapore

4.40 Resource Allocation & Implementing an Effective TalentDevelopment ProgramPrabhuram Krishnan, Medical Director, Eli Lilly and Company,Philippines

5.20 Early Access Program (EAP) for Patients – OncologyManish Garg, Medical Director, MSD Pharmaceuticals,Singapore

6.00 Chairperson’s Closing Remarks & End of Forum

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“Good mix of investigators, sites, pharmas andpartners... led to lively discussions, goodparticipation”Takeda Clinical Research

“An excellent conference, very interactive andI certainly learned a lot”Boehringer Ingelheim Pharmaceuticals


WORKSHOPS

Conference Workshop: 3 August 2015 | Monday


RMA

Michel Mikhail, Expert in International Global Regulatory Affairs,Germany

Dr Arun Gowda, Director of Focus Scientific Research Center, Pharmax,India

Networking Luncheon

Registration in the ASEAN Region: Overview of DossierRequirements, Time-Frames and Registration Procedures (continued)Michel Mikhail, Expert in International Global Regulatory Affairs,Germany Lyle Joseph Morrell, Corporate Development Officer, Metro Pacific

Investments Corporation, Philippines

Conference Workshop: 6 August 2015 | Thursday


RMA

John Wong, Senior Partner & Managing Director, Boston ConsultingGroup, ChinaZarif Munir, Partner and Managing Director, Boston Consulting Group,Malaysia

9.10 Chairperson’s Opening AddressYuko Kikuchi, Senior Director Asia Regulatory Affairs, Eisai, Japan

Clinical Regulatory Pathways: Timelines, Submissions and RegulatoryChallenges of Conducting Local Clinical Trials in Key Regions

9.15 JapanYuko Kikuchi, Senior Director Asia Regulatory Affairs, Eisai, Japan

10.00 ThailandNoppadon Adjimatera, SEA Regional Regulatory and MedicalAffairs Director, Reckitt Benckiser, Thailand

11.15 PhilippinesJulie Anne Odarbe, Regulatory Affairs Manager, AllerganHealthcare, Philippines

11.55 VietnamThao Nguyen, Regulatory and Government Affairs Director, Roche,Vietnam

Regulatory Strategies for Clinical Trials (continued)

2.00 IndiaPremnath Shenoy, Regulatory Affairs Director, AstraZeneca,India

2.45 Bridging Studies and Waivers in AsiaShun Jin, Regulatory Policy & Intelligence Director, JAPAC, AbbVie,Singapore

4.00 Challenges in Drug Safety and Efficacy ReportingPai Raghavendra, Regional Pharmacovigilance Manager,Lundbeck Singapore

China and IndoChina (continued)

John Wong, Senior Partner & Managing Director, Boston ConsultingGroup, ChinaZarif Munir, Partner and Managing Director, Boston Consulting Group,Malaysia

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POST

Networking Luncheon

Workshop E • 9.00am - 5.00pm

Regulatory Strategies for Clinical Trials

Workshop D • 9.00am - 5.00pm

Workshop B • 9.00am - 12.30pmWorkshop A • 9.00am - 5.00pm

Registration in the ASEAN Region: Overview of DossierRequirements, Time-Frames and Registration Procedures

Improving Market Access Using Real WorldEvidence Strategies

Workshop C • 1.30pm - 5.00pm

Philippines

China and IndoChina

MultipleEvents

1 UniqueBusiness Platform

MultipleEvents

1 UniqueBusiness Platform

Produced by:

International Marketing Partner:

LifeSciences

Media Partners:


IBCLIFE SCIENCES

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3 - 6 August 2015 | Grand Copthorne Waterfront Hotel, Singapore

IBC’s PharmaCon Asia will bring together key industry leaders from different regions in AsiaPacific, Europe, Middle East and US to meet, network and exchange ideas to drive innovation,investment and development in Asia’s growing pharmaceutical sector.

Gain Insight on Asia’s Unique & ComplexPharmaceutical Environment Today!

Where are the investment opportunities in Asian led research and drugdevelopment?Who is taking the lead?What is the latest progress with clinical development in Asia?How are regulations and approval processes evolving?How do you access key markets in Asia successfully?What are the key considerations to optimize success and profitability inAsia’s markets?

“High quality speakers — Strategic inputsvaluable for my day today” ~ AstraZeneca

“Very interactive with case based learningapproaches” ~ Abbott Healthcare

“Learned much on therole of MSL”

~ Janssen Singapore

TOP REASONS TO ATTEND!Official Opening Visionary Sessions – Senior level executives from TOP pharmacompanies will address the opportunities, issues and challenges for Asian led drug research anddevelopment

80+ Top Level Speakers – Meet and hear from renowned global and regional pharma speakers

Customize your Conference Learning & Experience – Choose your Own SessionsAcross 3 Special Focused Conferences Addressing Pertinent Issues Faced Today

The Ideal Networking Platform – 1 Location for you to Meet and Network across thePharmaceutical Value Chain

Don’t Miss NEW Interactive Pre & Post Conference Forums – Gain even more insight andvalue from leading CROs and Pharma Expert Speakers

THE FOLLOWING COMPANIES HAVE ALREADY CONFIRMED THEIR ATTENDANCE

Supported Organisation:

Bronze Sponsor: Exhibitors:

• Merck Serono• Eisai• Sanofi• Johnson & Johnson• Mebiopharm• Luqa Pharmaceuticals• PharmAbcine• Aslan Pharmaceutical• Taiwan Food and Drug

Administration (FDA)• Food and Drug Administration

(FDA) Philippines• Novartis Asia Pacific

Pharmaceuticals• Boehringer Ingelheim

Pharmaceuticals• Austrian Agency for Health and

Food Safety (AGES) PharmMed• European Medicines Agency

(EMA)• Administration of Science,

Technology and Training (ASTT),Vietnam Ministry of Health

• BeiGene• MSD, India• Roche Vietnam• Pfizer• Janssen• TEVA UK• GSK

• Takeda Pharmaceuticals• Smart Research• Baxter Limited• Aspen Philippines• CIMB Investment Bank• Bayer Healthcare• Astellas Pharma• Merck Serono China• A*Star• Reckitt Benckiser• IPMG• Novartis Indonesia• Pfizer Thailand• Singapore Clinical Research

Institute

• ARPA• PT Rama Emerald Multi Sukses• AbbVie• Eli Lilly & Co Philippines• ALMAC• Actavis• Cadila Pharmaceuticals• ERT• Daiichi Sankyo• Boehnringer Ingelheim• Sanbe Farma• Novel Laboratories• Fresenus Kabi• Metro Pacific Investments• Pharmax India

• Mylan Laboratories• Novel Laboratories• Quintiles• INC Research• Novotech• ClinTec International Group• Allergan Healthcare• PACRA• Takeda Development Centre Asia• Parexel International

Plus Many More...

“Eye opening event toknow and interact withpeers” ~ Pfizer China

Session Spotlight Sponsors:

Who is Head of your Department?Who is Head of Training?

Company InformationCompany Name:

Address:

Main Business/Activity:

Postal Code:

If undelivered, please return to:

111 Somerset Road,TripleOne Somerset #10-05, Singapore 238164Tel: +65 6508 2400 Fax: +65 6508 2408

PHARMACON ASIA

[email protected]

Fax+65 6508 2407

Scan the QR Code with yoursmartphone and register today

Customer Service Hotline+65 6508 2401

MAIL the attached registrationform with your cheque toIBC Asia (S) Pte Ltdc/o Informa Regional BusinessServices111 Somerset Road,TripleOne Somerset #10-05,Singapore 238164

Webwww.pharmaconasia.com

HOTEL INFORMATION

DATA PROTECTION

PAYMENT TERMS

CANCELLATIONS / SUBSTITUTION

IMPORTANT NOTE

REG

NO. 2

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8203

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Payment must be received 10 business days prior to the event.To take advantage of discounts with an expiry date, registrationand payment must be received by the cut-off date.• Payment by bankers draft or cheque in S$ or US$ should be

made in favour of “IBC Asia (S) Pte Ltd” and mailed to:IBC Asia (S) Pte Ltdc/o Informa Regional Business Services111 Somerset Road, TripleOne Somerset #10-06Singapore 238164Attn: The Accounts Receivable Team

• Payment by bank transfer in S$ or US$ made payable to:IBC Asia (S) Pte LtdA/C No.:147-059513-001 (S$)A/C No.:260-457866-178 (US$)The Hongkong and Shanghai Banking Corporation Limited21 Collyer Quay, HSBC BuildingSingapore 049320Bank Swift Code: HSBCSGSGBank Code: 7232

• Payment by Credit Card (AMEX, VISA or MasterCard).The best way to pay by credit card is through our secureportal built into the website. To pay by phone please indicatethe contact name and details below and our CustomerServices Team will call within 24 hours to take payment.Please do not send credit card information by email.

The personal information entered during your registration/order,or provided by you, will be held on a database and may beshared with companies in the Informa Group in the UK andinternationally. Occasionally, your details may be obtained fromor shared with external companies who wish to communicatewith you offers related to your business activities. If you do notwish your details to be used for this purpose, please contactour Database Department at Email: [email protected],Tel: +65 6508 2400 or Fax: +65 6508 2408.

Should you be unable to attend, a substitute delegate iswelcome at no extra charge. Cancellations must be received inwriting at least 10 business days before the start of the event,to receive a refund less 10% processing fee per registration.The company regrets that no refund will be made available forcancellation notifications received less than 10 business daysbefore the event.

Please quote the name of the delegate, event title and invoicenumber on the advice when remitting payment. Bank chargesare to be deducted from participating organisations own accounts.Please fax your payment details (copy of remittance advice,cheque or draft to +65 6508 2407).Attendance will only be permitted upon receipt of full payment.Participants wishing to register at the door are responsible toensure all details are as published. IBC assumes no furtherliability or obligation, beyond the refund of the paid registrationfee, in the event of postponement or cancellation by IBC.

6 EASY WAYS TO REGISTER

RESERVE YOUR PLACE TODAY!■ Yes! I/We will attend the PHARMACON ASIA

3 – 6 August 2015, Grand Copthorne Waterfront Hotel, Singapore■ I would like to purchase the conference presentations at SGD1000 + GST (SGD1070) per log in.

CREDIT CARD PAYMENTSThe best way to pay by credit card is through our secure on-line registration process, simply log on to the website atwww.pharmaconasia.com and click “Register On-line”. If you would prefer to pay over the phone please complete the contact nameand details and our Customer Services Team will call within 24 hours to take payment. As we treat your credit card information in thestrictest confidence, please do not send payment details by email.

Credit card contact: Department:

Direct phone number: Email:

P46285

■ I enclose my bankers draft / cheque payable to IBC Asia (S) Pte Ltd■ I am paying by bank transfer (copy attached)■ Payment by Credit Card. (AMEX, VISA or MasterCard accepted)

PAYMENT METHOD(Please tick)

• Multiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisation registering for the same event, at the same time.Fee stated is the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR special rate OR group rate.

• All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.• Registration fees are subject to the prevailing government tax.

❑ 2 Day Conference only

FEE PER DELEGATE

❑ 4 Day Package SGD 4,095 SGD 4,295 SGD 4,495 SGD 4,095❑ 3.5 Day Package❑ 3 Day Package❑ 2.5 Day Package

SGD 3,895 SGD 4,095 SGD 4,295 SGD 3,795SGD 3,595 SGD 3,795 SGD 3,995 SGD 3,495SGD 3,295 SGD 3,495 SGD 3,695 SGD 3,195SGD 2,895 SGD 3,095 SGD 3,295 SGD 2,795

ALL ACCESS PASS TO PHARMACON

Register 3 Delegates andThe 4th Attends For Free!


Group Rate(3 or more delegates)

GRAND COPTHORNE WATERFRONT HOTEL,SINGAPORE392 Havelock Road, Singapore 169663.Tel: +65 6233 1301 | Fax: +65 6233 1177International Reservation: +65 6735 7575Contact: Tan Ai Li, Director of EventsEmail: [email protected]: +65 6233 1301

Early Bird RateRegister & pay on orbefore 29 May 2015

Special RateRegister & pay on orbefore 26 June 2015

Normal RateRegister & pay after

26 June 2015

4 - 5 August 2015 • Tick the Main Conference of Interest❑ Clinical Trials Asia ❑ Pharma Regulatory Affairs❑ Pharma Market Access3 and 6 August 2015 • Tick the Workshop(s) You Would Liketo Attend3 August • Pre-Conference 0.5 Day Workshops❑ Improving Market Access Using Real World Evidence

Strategies❑ Philippines3 August • Pre-Conference 1 Day Workshop❑ Registration in the ASEAN Region: Overview of Dossier

Requirements, Time-Frames and Registration Procedures

6 August • Post-Conference 1 DayWorkshops❑ China and IndoChina❑ Regulatory Strategies for Clinical Trials

3 and 6 August 2015 • Tick the Pre or PostConference Forum3 August • Pre-Conference 1 Day Forum:❑ Leadership in Clinical Outsourcing6 August • Post-Conference 1 Day Forum❑ Medical Affairs

Name: Dr/Mr/Ms

Job Title: Department

Tel: Mobile No.:

Email:Please photocopy for additional delegates

3 - 6 August 2015Grand Copthorne Waterfront Hotel, Singapore


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Health & Medicine